The GAV General Anesthetic Vaporizer is a concentration-calibrated device intended to deliver specific anesthetic agents into the fresh gas supply of an anesthesia workstation or anesthesia gas machine. The volatile agents intended to be used with this device are: Isoflurane, Sevoflurane and Halothane.

Device Description

The GAV – General Anaesthetic Vaporizer is designed for use in continuous flow techniques of general anesthesia. It has a finely graduation that occipis and temperatures. Safety features such as unteriged Over a wide range of ther see incorporated together with many convenience features intenoun, Nor-oplir and Reyou Fillor are meet persition. GAV vaporizers are agent specific and are clearly labelled and colour coded for additional safety.

AI/ML Overview

The provided document is a 510(k) summary for the GAV – General Anaesthetic Vaporizer. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device (Tec 5 Continuous Flow Vaporizer) based on clinical and technical comparisons. However, it does not include detailed information regarding acceptance criteria, a specific study proving those criteria, or the methodology (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) typically associated with such studies for AI/ML-based devices.

The document primarily focuses on demonstrating equivalence to an existing device through comparison of features and performance characteristics, rather than establishing performance against specific, quantifiable acceptance criteria through an independent study as one might expect for a novel AI/ML medical device.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be provided based on the input:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in this summary. The document discusses "similar relevant performance according to expected clinical effect" and "similar specifications and properties (Accuracy, temperature range, flow range, pressures and output matches the set concentration and remains constant over a number of changing/changeable variables)." However, it doesn't provide specific numerical acceptance criteria.
Reported Device Performance: The document states that the device's output "matches the set concentration and remains constant over a number of changing/changeable variables." This is a qualitative statement of performance, but specific numerical performance results (e.g., ±X% accuracy) are not provided in this summary. It mentions "non-clinical tests the results of which are detailed in Section 4," but Section 4 itself is not provided in the input.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document is for a mechanical vaporizer, not a data-driven AI/ML device. Therefore, a "test set" in the context of data for AI/ML is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. As above, this is not an AI/ML device, and no ground truth establishment through expert review of data is described. The equivalency claim is based on engineering design, materials, and expected functional performance likened to the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is a mechanical vaporizer, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided in the traditional sense. The "ground truth" for a mechanical device like this would typically be established through engineering specifications, reference standards, and performance testing against those standards (e.g., flow meters, gas analyzers, temperature sensors). This summary does not detail the specific ground truth methodologies for the non-clinical tests it references.

8. The sample size for the training set

Not applicable/Not provided. This is a mechanical device, not an AI/ML device that uses a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device that is a mechanical anesthesia vaporizer. It does not contain the type of AI/ML-specific study information requested. The "proof" of the device meeting its intended function relies on non-clinical tests (results not detailed here) and a comparison to a legally marketed predicate device with similar design, materials, and clinical/technical performance characteristics.

Summary

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KOSIolde

AUG 2 3 2005

510(k) Summary

Submitter

General Anaesthetic Services Limited Worth Valley House Ingrow Bridge Business Park Halifax Road Keighley West Yorkshire BD21 5EF UK 044 (0)1535 609615 Tel:

044 (0) 1535 691033 Fax:

Contact:	Andrew J W Wall, Quality Manager
Summary Prepared:	18 April 2005	Rev. 0
Summary Amended:	12 July 2005	Rev. 1

Name of Device

Trade Name:	GAV - General Anaesthetic Vaporizer
Common Name:	Vaporizer
Classification Name:	Vaporizer, Anesthesia, Non-Heated
Product Code:	CAD
Regulation Number:	21 CFR 868.5880

Legally Marketed Device on which equivalence is claimed

Trade Name:	Tec 5 Continuous Flow Vaporizer
Common Name:	Vaporizer
Classification Name:	Vaporizer, Anesthesia, Non-Heated
Product Code:	CAD
Regulation Number:	21 CFR 868.5880
510(k) Number:	K892057

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Description of the Device

The GAV – General Anaesthetic Vaporizer is designed for use in continuous flow techniques of THE GAV – General Anacotherio Tuponized to Goughed with an output which remains largely general anesthesia. It has a finely graduation that occipis and temperatures. Safety features such as unteriged Over a wide range of ther see incorporated together with many convenience features intenoun, Nor-oplir and Reyou Fillor are meet persition. GAV vaporizers are agent specific and are clearly labelled and colour coded for additional safety.

Intended Use

Indications For Use:

General anesthesia may be produced using techniques of inhalation anesthesia and in such cases the use of an anesthetic vaporizer such as the GAV will be indicated.

Non-Clinical Performance Data

The pre-market notification references non-clinical tests the results of which are detailed in Section 4.

Summary of Comparisons - GAV v Tec 5

Clinical:

Used for the same clinical purpose (to induce and/or maintain required depths of inhalation anaesthesia in patients)

Used at the same site in the body (connected to the patient breathing circuit via the Selectatec system and the common gas outlet of the anaesthetic machine)

Used on similar patient populations (Ages, anatomy, physiology etc.)

Has similar relevant performance according to expected clinical effect for the specified intended use (output matches the set concentration and remains constant over a number of changing/changeable variables)

Technical:

GAV used under similar conditions of use (used in appropriate clinical environments)

Has similar specifications and properties (Accuracy, temperature range, flow range, pressures and output matches the set concentration and remains constant over a number of changing/changeable variables)

Is of similar design

(Mechanical with single, direct-reading control dial which is calibrated in volumes percent (% V/V), compatible with Selectatec system, integral interlock, keyed filler, liquid level indicator.

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Has similar principles of operation

Has Similar principles over with wicks. For use outside the (Vanable bypass, frow Over thin minnensation by automatic flow variation. Agent specific)

Manufactured from similar materials

Manufactured from Similar mater, aluminium, bronze, stainless (Specified grades of brace, copper), Glass, cotton, metal foil. Steel, themnoplastics, FT E and rabs and wax. Electroplating and anodizing.)

Biological:

(Connected to the patient breathing circuit via the Selectatec system and the (Oonnoolou to the pof the anaesthetic machine)

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines that suggest the wings and body of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2005

General Anaesthetic Services, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K051666

Trade/Device Name: GAV - General Anaesthetic Vaporizer Regulation Number: 21 CFR 868.5880 Regulation Name: Anaesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: August 11, 2005 Received: August 15, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suser Runner

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

Not yet known 510(k) Number (if known):

GAV - General Anaesthetic Vaporizer Device Name:

Indications For Use:

US Federal law restricts this device for sale by or on the order of a licensed physician

Prescription Use Applicable (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use Not Applicable (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cura Sulton

510(k) Number:

Page 1 of 1

Page 76 of 103

Regulation Number and Section

§ 868.5880 Anesthetic vaporizer.

(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).